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FDA 510(k)

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION

K-Number: K132272 · 2013-10-17

ApplicantGlooko, Inc.
Decision Date2013-10-17
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Glooko, Inc.. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K132272. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Glooko, Inc.. The 510(k) number is K132272.

When did GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION receive FDA 510(k) clearance?

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION received FDA 510(k) clearance on 2013-10-17, under 510(k) number K132272.

Who is the listed applicant for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

The FDA 510(k) record lists Glooko, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

The FDA product code for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Other records listing Glooko, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260910EndoTool IV Cloud 1.0K171450Glooko Mobile Insulin Dosing SystemK130886GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATIONK122142GLOOKO LOGBOOK CHARTS

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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